ATLANTA - Mar 21, 2014 - Pharmacokinetic (PK) data supporting the dose and schedule regimens of Biothera’s phase 3 cancer immunotherapy Imprime PGG® are being presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting in Atlanta this week
ATLANTA - Mar 21, 2014 - Pharmacokinetic (PK) data supporting
the dose and schedule regimens of Biothera's phase 3 cancer
immunotherapy Imprime PGG® are being presented at the American
Society for Clinical Pharmacology and Therapeutics Annual Meeting
in Atlanta this week.
The results are based on population pharmacokinetic data
generated from four clinical trials that included two phase 1
safety studies in healthy volunteers, a phase 1b/2 study in
colorectal cancer patients receiving cetuximab with or without
irinotecan, and a phase 2 study in non-small cell lung cancer
patients receiving cetuximab with carboplatin and paclitaxel. Key
findings included:
- Clearance of Imprime PGG in cancer patients treated with
monoclonal antibodies with or without chemotherapy was similar to
that in healthy volunteers.
- The effective half-life of Imprime PGG ranged from 19.5 to 27.3
h. Based on modeling and simulations, negligible or minimal
accumulation of Imprime PGG was observed with weekly dosing in
cancer patients, supporting a weekly dose regimen.
- Exposure to Imprime PGG was similar in patients who were
positive or negative for a biomarker correlated with response to
Imprime PGG in patients with non-small cell lung cancer.
"These results indicate that there were no apparent drug-drug
interactions or concerns about clearance or accumulation following
administration of Imprime PGG," said Myra Patchen, Ph.D., Biothera
chief scientific officer. "The PK data support the dose and
schedule regimen for Imprime PGG in our clinical studies."
Certara contributed to the findings through population PK
modeling of Imprime PGG to support the dosing rationale and assess
potential drug-drug interactions with cetuximab, with and without
irinotecan,
"Certara is delighted to partner with Biothera on this important
project," said JF Marier, Ph.D., lead author, and vice president
and lead scientist for Certara. "This is an excellent example of
how population PK modeling can be used to support dosing of cancer
patients in clinical studies."
Biothera's PK data is the subject of two presentations:
About Imprime PGG®
Imprime PGG is a novel cancer immunotherapy that engages and
directs the innate immune system to kill cancer cells. This
targeted mechanism is synergistic with all anti-tumor monoclonal
antibodies tested to date, demonstrating significant therapeutic
potential in a wide range of cancer indications. In phase 2
clinical trials, Imprime PGG has demonstrated marked improvements
in response rates in multiple clinical trials for
non-small cell lung cancer (NSCLC),
colorectal cancer and
chronic lymphocytic leukemia. Imprime PGG is currently being
investigated in a phase 3 clinical trial for advanced colorectal
cancer and a second phase 2 study for NSCLC. Website: www.biothera.com/pharma.
About Biothera, the Immune Health Company
Biothera is a U.S. biotechnology company dedicated to improving
immune health. The company is a pioneer in the field of cancer
immunotherapy and the leader in innate immune modulation.
About Certara
Certara is the leading technology-enabled drug development
consultancy. Headquartered in St Louis, MO, with offices in the UK,
Canada, and Japan, Certara has more than 225 employees worldwide.
The company delivers model-based drug development and discovery
solutions including molecular modeling, physiologically-based
predictions of pharmacokinetics from in vitro and physiochemical
data, and modeling of pharmacokinetic and pharmacodynamic data from
preclinical and clinical studies.
Biothera Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com
Certara Contact:
Lisa Osborne
CEO
Rana Healthcare Solutions
206-992-5245
lisa@ranahealth.com